Extra physiotherapy in critical care: intensive versus standard physical rehabilitation therapy in the critically ill

ISRCTN	ISRCTN20436833
DOI	https://doi.org/10.1186/ISRCTN20436833
Secondary identifying numbers	11389

Submission date: 20/02/2012
Registration date: 20/02/2012
Last edited: 09/08/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
An increased intensity of physiotherapy, including an individualised structured exercise programme, may be beneficial for critically ill patients. The aim of this study is to compare two intensities of physiotherapy in critically ill patients.

Who can participate?
Critically ill surgical or medical patients, over 18 years of age, who have been ventilated for between 48 and 72 hours

What does the study involve?
Participants are randomly allocated to one of two groups. Group 1 (control group) receive usual physical rehabilitation therapy (Monday to Friday), including a once-daily functional retraining session. Group 2 (intervention group) receive a more intensive physical rehabilitation therapy, including at least one functional retraining session per day (Monday to Friday), and an individualised structured exercise programme. Physical quality of life is compared on Critical Care discharge and 3 and 6 months later. Changes in participants' mental health and the economic costs of the interventions are also assessed.

What are the possible benefits and risks of participating?
The possible benefits of participating are that if additional physiotherapy is shown to be beneficial to Critical Care patients, research participants will also benefit. This could be shown as improvements to physical function, longer-term health, exercise capacity and overall quality of life. During physiotherapy sessions, research participants will be monitored closely, and if any specific events occur, the session will be stopped. Research participants are patients who are already critically ill, and so additional precautions will be taken to ensure that the risks of participating are minimised.

Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2012 to June 2015

Who is funding the study?
National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB)

Who is the main contact?
Miss Gillian Watson
gillian.watson@ncl.ac.uk

Contact information

Miss Gillian Watson
Scientific

Newcastle Clinical Trials Unit
Institute of Health & Society
Newcastle University
4th Floor, William Leech Building
Medical School
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 8813
Email	gillian.watson@ncl.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact gillian.watson@ncl.ac.uk to request a patient information sheet
Scientific title	A randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill: Extra Physiotherapy In Critical Care
Study acronym	EPICC
Study objectives	This study aims to compare two intensities of physiotherapy in critically ill patients. The trialists believe that an increased intensity of physiotherapy, including an individualised structured exercise programme, will be beneficial for critically ill patients. To assess this, their physical quality of life will be compared on Critical Care discharge, and at 3 and 6 months following initial recruitment to the study. Changes in participants' mental health and the economic costs of the interventions will also be assessed.
Ethics approval(s)	South Central - Southampton B Research Ethics Committee, first MREC approval date 20/07/2011, ref: 11/NE/0206
Health condition(s) or problem(s) studied	Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care
Intervention	Group 1 (control group) will receive usual physical rehabilitation therapy (Monday to Friday), including a once-daily functional retraining session. Group 2 (intervention group) will receive a more intensive physical rehabilitation therapy, including at least one functional retraining session per day (Monday to Friday), and an individualised structured exercise programme.
Intervention type	Behavioural
Primary outcome measure	Physical QoL; Timepoint(s): 6 months
Secondary outcome measures	1. Changes in mental health; Timepoint(s): 6 months 2. Economic costs of intervention; Timepoint(s): 6 months
Overall study start date	16/01/2012
Completion date	04/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 308; UK Sample Size: 308
Key inclusion criteria	1. Participant has provided written informed consent, or their Personal Consultee has provided a signed Personal Consultee Declaration Form, for participation in the study, prior to any study specific procedures taking place 2. Medical and surgical patients (surgical patients are those admitted to ICU as a direct consequence of an operative procedure, or as a consequence of that procedure. All other patients are termed medical) 3. Age 18 years or over 4. Invasive or noninvasive ventilation for more than 48 hours Target Gender: Male & Female ; Lower Age Limit 18 years
Key exclusion criteria	1. Invasive or non-invasive ventilation for more than 72 hours 2. Under 18 years 3. Patients receiving end-of-life care 4. Patients not expected to survive for more than 48 hours after enrolment 5. Acute brain injury 6. Acute spinal cord injury 7. Spinal surgery 8. Brain surgery 9. Multiple trauma 10. Burns 11. Rapidly progressive neuromuscular disease 12. Enrolment in another clinical trial 13. Post-cardiac arrest
Date of first enrolment	16/01/2012
Date of final enrolment	04/12/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Newcastle University

Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Wolfson Unit of Clinical Pharmacology
Institute of Cellular Medicine
Framlington Place
Newcastle Upon Tyne
NE2 4HH
England
United Kingdom

"ROR"	https://ror.org/05p40t847

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme (RfPB)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	25/05/2015		Yes	No
Results article	results	01/03/2018		Yes	No

Editorial Notes

09/08/2017: Publication reference added.
26/02/2015: The overall trial end date was changed from 03/07/2014 to 04/06/2015.